Overview
The objective of this clinical trial is to collect safety and effectiveness data for the TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in the APAC patient population for the treatment of drug refractory, symptomatic persistent atrial fibrillation when following standard electrophysiology mapping and radiofrequency (RF) ablation procedures.
Description
The PerAF APAC trial is a prospective, single arm, non-randomized, observational, post-market clinical investigation. Approximately 100 subjects will be enrolled at up to 15 sites in South Korea, Singapore, Hong Kong, Taiwan, and India. Centers in other countries within APAC may be approached for participation in the clinical investigation as needed. Subjects will be followed for 15-months after their initial ablation procedure. The primary effectiveness and safety endpoints will be evaluated through 15-months. A core lab will independently assess AF/AFL/AT recurrence via Holter monitoring at the 6-month and 15-month follow-up visits. All serious adverse events (SAEs) will be independently adjudicated by qualified physicians not participating in the trial
Eligibility
Inclusion Criteria:
- Signed informed consent
- Documented symptomatic persistent AF, defined as continuous AF sustained >7-days but <1 year documented by:
- Physician's note AND one of the following:
- 24-hr Holter showing continuous AF within 90-days of the procedure OR
- 2 ECGs (from any form of rhythm monitoring) showing continuous AF, taken at least 7-days apart
- Refractory or intolerant to at least one Class I or III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF NOTE: Intolerant = unable, unwilling, or refusal to take AADs
- 18 years of age
- Able and willing to complete all pre-, post-, and follow-up testing and requirements
Exclusion Criteria:
- Continuous AF >12 months.
- Previous left atrial (LA) surgical or catheter ablation for AF
- Any cardiac procedure within 90-days prior to procedure (Diagnostic procedures with no intervention are not considered a surgical or percutaneous surgical procedure)
- Coronary artery bypass graft (CABG) surgery within 6-months prior to procedure
- Valvular cardiac surgical/percutaneous procedure
- Any carotid stenting or endarterectomy
- Documented LA thrombus on imaging
- LA diameter >50 mm
- Left Ventricular Ejection Fraction (LVEF) <40%
- Unable to take anticoagulation medication
- History of blood clotting or bleeding abnormalities
- Myocardial Infarction (MI), acute coronary syndrome, Percutaneous coronary intervention (PCI) within the 3-mos prior to the procedure
- Documented thromboembolic event within 12-months prior to the procedure
- Rheumatic heart disease
- Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
- Severe mitral regurgitation
- Cardiac transplantation or other cardiac surgery within 12-months of the ablation procedure
- Unstable angina at the time of the procedure
- Acute illness or active systemic infection
- AF secondary to non-cardiac or reversible causes
- Diagnosed atrial myxoma
- Presence of intracardiac defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
- Significant pulmonary disease that produces chronic symptoms
- Significant congenital anomaly or other anatomic or comorbid condition that may impact scientific soundness of study
- Pregnant or nursing subjects
- Enrollment in another study that may interfere with this study
- Presence of a condition preventing appropriate vascular access
- Life expectancy <12-months
- BMI >40 kg/m2
- Known sensitivity to contrast media
- Renal failure requiring dialysis
- Presence of other medical, social, or psychological condition that in the investigator's opinion, limits the subject's ability to participate in the study or impact the scientific soundness of the study
- History of atriotomy or ventriotomy
- Implanted left atrial appendage occlusion device